What are the biggest regulatory challenges facing Pharma use of blockchain technology

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Being closer to the financial services industry, I'm very aware of the various challenges facing that industry as it looks for opportunities to use blockchain technologies. Aside from the obvious concerns about privacy and security, are there other less obvious regulatory/legal impediments to using blockchain tech to solve pharma challenges?

Mike Evans
60 months ago

2 answers

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Although I've been more focused on the Dx side of healthcare, I have been looking into the potential uses for blockchain tech in the healthcare field in general. I've seen a good deal of research into usage for medical records and telemedicine, but not as much about its use in Pharma, for which I guess you mean more on the supply chain/drug distribution side? Or also clinical research?
There is a very recent study that I'm aware of by the IEEE that would likely yield useful information called "State of Blockchain Adoption on the Pharmaceutical Supply Chain". However, it's quite expensive. Here's a writeup about it: http://www.pharmtech.com/ieee-releases-first-study-blockchain-adoption-pharmaceutical-industry
Generally it had this info on barriers but it doesn't go deep into legal/reg issues but maybe it does in the full report:
"As far as top barriers to adoption, wholesalers and dispensary executives saw the main obstacles as lack of user buy-in, the typical challenges that result from implementing any new technology, and the need to connect to all networks. Manufacturers saw cost, security and network connectivity and integration as top concerns.
All three groups cited regulatory uncertainty and the need to understand how FDA would define the compliant use of blockchain, as well as visibility of the data and trust, given their supply chain partners’ ability to view company information in an autonomous system."
One issue that sets pharma apart from other distribution networks is the need for temperature control. I found this article about one company using blockchain based systems to solve such issues
https://www.smithandcrown.com/sale/modum-io-blockchain-based-monitoring-reporting-supply-chain-conditions/
Unfortunately I'm not aware of any specific legal barriers to using blockchain in pharma, especially as it's so new and there are no standards set, but I'm interested in seeing what others say.

Mark Whitten
60 months ago
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Other than Privacy and may be proving to the FDA that block-chain data is good science for the clinical program of a product I am not aware of any other concerns at this time.
Below is a link to a conference about to take place in Nov [Disruptive Rx Summit] that may shed some additional light...
http://disruptiverxsummit.com/
www.RXBlockchainBootcamp.com

Michaela Griggs
60 months ago

Have some input?